NCT06447116

Brief Summary

The Jacobs Institute is conducting a Sponsor Investigator study of patients ≥ 18 years to establish safety and preliminary effectiveness in treating extracranial stenosis with the CGuard Prime™ Carotid Stent in the setting as an acute ischemic stroke.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

June 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

June 3, 2024

Last Update Submit

March 3, 2026

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with mRS ≤ 2 at 90 days

    Proportion of subjects with mRS ≤ 2 at 90 days

    90 days

Secondary Outcomes (1)

  • Rate of TICI 2b or greater; Proportion of subjects with sICH within 24 hours; and New stroke within the same territory within 7 days.

    7 days

Study Arms (1)

C Guard Arm

EXPERIMENTAL
Device: CGuard Prime™ Carotid Stent System

Interventions

CGuard Prime™ Carotid Stent SystemDEVICE

CGuard Prime™ Carotid Stent System

C Guard Arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18-year-old; Carotid stenosis with at least ≥ 50% stenosis; National Institute of Health Stroke Scale (NIHSS) \>/=6; and evidence of large vessel occlusion (LVO) in the anterior circulation (i.e., intracranial internal carotid artery, M1 and proximal M2) by computed tomography angiography (CTA).

You may not qualify if:

  • Cannot provide consent or legally authorized representative not available to provide consent. Evidence of intracranial hemorrhage on non-contrast CT or MRI; ASPECTS\<6; and any contraindication to dual antiplatelet therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacobs Institute

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • CARLOS LOUIS PENA, PhD

    Jacobs institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 6, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)